HIRREM Developmental Study

NCT02709369 | Completed Results FDA Device

• 1 other identifier: IRB00017651
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety; Post-Traumatic Stress Disorder; Hot Flashes; Headache; Traumatic Brain Injury; Post Concussion Symptoms

Keywords

HIRREM; Neuro-technology; Closed-loop; Acoustic stimulation; Allostatic; heart rate variability; baroreflex sensitivity; traumatic brain injury; sports concussion; PTSD; hot flashes; headache; insomnia

Outcome Measures

Primary Outcomes (10)

• Heart Rate Variability Standard Deviation of NN Intervals (SDNN)

  Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

  Baseline/Enrollment visit

• Heart Rate Variability (SDNN)

  Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

  Up to 2 weeks after the intervention is completed

• Baroreflex Sensitivity High Frequency (HF) Alpha

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Baseline/Enrollment visit

• Baroreflex Sensitivity High Frequency (HF) Alpha

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Up to two weeks after the intervention is completed

• Baroreflex Sensitivity Sequence Up

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Baseline/Enrollment visit

• Baroreflex Sensitivity Sequence Up

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Up to two weeks after the intervention is completed

• Baroreflex Sensitivity Sequence Down

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Baseline/Enrollment visit

• Baroreflex Sensitivity Sequence Down

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Up to two weeks after the intervention is completed

• Baroreflex Sensitivity Sequence All

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Baseline/Enrollment visit

• Baroreflex Sensitivity Sequence All

  Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  Up to 2 weeks after the intervention is completed

Secondary Outcomes (21)

• Center for Epidemiologic Studies Depression Scale (CES-D)

  enrollment visit/baseline

• Center for Epidemiologic Studies Depression Scale (CES-D)

  1-2 weeks after intervention is completed

• Center for Epidemiologic Studies Depression Scale (CES-D)

  4-8 weeks after completion of the intervention

• Euro Quality of Life--Five Dimension (EQ-5D)

  enrollment visit/baseline

• Euro Quality of Life--Five Dimension (EQ-5D)

  1-2 weeks after the intervention is completed

Other Outcomes (5)

• Heart Rate Variability Standard Deviation of NN Intervals (SDNN)

  4-8 weeks after completion of the intervention

• Baroreflex Sensitivity High Frequency (HF) Alpha

  4-8 weeks after completion of the intervention

• Baroreflex Sensitivity Sequence Up

  4-8 weeks after completion of the intervention

Study Arms (1)

Active HIRREM

EXPERIMENTAL

This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.

Device: HIRREM

Interventions

HIRREM DEVICE

HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.

Active HIRREM

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults and children aged 11 years and older.
• Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
• Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
• Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.

You may not qualify if:

• Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
• Subjects physically unable to come to the study visits.
• Subjects with a known seizure disorder.
• Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
• Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
• Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (10)

• Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.

  PMID: 23532171 BACKGROUND

• Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.

  PMID: 23170244 BACKGROUND

• Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507. No abstract available.

  PMID: 24599239 BACKGROUND

• Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015.

  PMID: 26347688 BACKGROUND

• Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014.

  PMID: 25136325 RESULT

• Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422.

  PMID: 25668305 RESULT

• Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1.

  PMID: 26085968 RESULT

• Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8.

  PMID: 26645307 RESULT

• Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14.

  PMID: 27747793 RESULT

• Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, Shaltout HA, Simpson SL, Fidali BC, Gerdes L, Lee SW. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. BMC Psychiatry. 2017 Apr 19;17(1):141. doi: 10.1186/s12888-017-1299-x.

  PMID: 28420362 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic; Hot Flashes; Headache; Brain Injuries, Traumatic; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Charles H. Tegeler
• Organization: Wake Forest School of Medicine

ctegeler@wakehealth.edu

+1 (336) 716-7651

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 16, 2016
• Study Start: August 23, 2011
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)